Packaging for pressure and gas sensitive products

Abstract

Disclosed are improved devices, systems and methods for storing, protecting and/or dispensing/delivering products that are particularly sensitive to pressure changes, alterations in gas distributions and/or partial pressures, physical impacts, temperature changes and/or other variations in the ambient environment.

The invention claimed is: 
     
       1. A method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient, comprising:
 placing the flowable microbubble composition within a first flexible and sealable enclosure, the first flexible and sealable enclosure including a substantially sterile first interior space; 
 inserting and suspending the first flexible and sealable enclosure completely within a second interior space of a second rigid and sealable enclosure and closing the second rigid and sealable enclosure to fully encapsulate the first flexible and sealable enclosure within the second interior space, wherein the second interior space comprises a plurality of interior walls and substantially all of the first flexible and sealable enclosure is spaced apart from the plurality of interior walls of the interior space; 
 maintaining the second rigid and sealable enclosure in a closed condition until at least a portion of the flowable microbubble composition is to be utilized for dispensing or use in the patient. 
 
     
     
       2. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 1 , wherein the second interior space is in a substantially sterile condition before insertion of the first flexible and sealable enclosure. 
     
     
       3. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 2 , wherein the second interior space remains in the substantially sterile condition after insertion of the first flexible and sealable enclosure. 
     
     
       4. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 1 , wherein the step of placing the flowable microbubble composition within a first flexible and sealable enclosure occurs prior to the step of inserting and suspending the first flexible and sealable enclosure completely within the second interior space of the second rigid and sealable enclosure. 
     
     
       5. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 1 , wherein the step of inserting and suspending the first flexible and sealable enclosure completely within a second interior space of the second rigid and sealable enclosure comprises placing a vibration dampening mount between the first flexible and sealable enclosure and the second rigid and sealable enclosure. 
     
     
       6. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 1 , wherein the step of inserting and suspending the first flexible and sealable enclosure completely within a second interior space of the second rigid and sealable enclosure comprises engaging a flexible link between the first flexible and sealable enclosure and the second rigid and sealable enclosure. 
     
     
       7. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 1 , wherein the step of closing the second rigid and sealable enclosure comprises securing a removable lid or cap to an opening of the second rigid and sealable enclosure. 
     
     
       8. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 1 , wherein a closure lid which closes the second rigid and sealable enclosure engages with the second rigid and sealable enclosure to create an airtight seal. 
     
     
       9. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 1 , wherein the second rigid and sealable enclosure further comprises an insulating container. 
     
     
       10. The method of protecting a flowable microbubble composition from contamination or damage prior to dispensing or use in a patient of  claim 8 , further comprising the steps of:
 slowly equalizing an air pressure within the second interior space with an atmospheric pressure located outside of the second rigid and sealable enclosure over a period of at least 2 seconds; and 
 opening a closure lid which was previously used to close the second rigid and sealable enclosure. 
 
     
     
       11. A container for protecting a flowable microbubble composition from contamination or damage prior to dispensing, comprising:
 a first flexible and sealable enclosure having at least one enclosure wall and a mounting structure positioned near a first end of the enclosure, the first flexible and sealable enclosure having a substantially sterile first interior space, the flowable microbubble composition contained within the substantially sterile first interior space; 
 a second rigid and sealable enclosure having a second interior space, the second interior space comprising an opening and a plurality of interior walls with at least one interior mounting point, the opening and second interior space sized and configured to accommodate the first flexible and sealable enclosure and flowable microbubble composition through the opening and within the second interior space without the at least one enclosure wall contacting the plurality of interior walls within the second interior space; 
 wherein when the first flexible and sealable enclosure is placed within the second interior space and a closure top is engaged with the second rigid and sealable enclosure to close the opening, the mounting structure engages with the at least one interior mounting point to suspend the first flexible and sealable enclosure within the second rigid and sealable enclosure and prevent contact between the at least one enclosure wall and the plurality of interior walls within the second interior space; and 
 the second rigid and sealable enclosure insulates the first flexible and sealable enclosure from exterior impacts and vibrations which contact the second rigid and sealable enclosure. 
 
     
     
       12. The container of  claim 11 , wherein the engagement between the mounting structure and the at least one interior mounting point comprises a vibration dampening assembly. 
     
     
       13. The container of  claim 11 , further comprising a first dispensing port extending through at least a portion of the at least one enclosure wall of the first flexible and sealable enclosure. 
     
     
       14. The container of  claim 11 , further comprising an external dispensing port extending through at least one of the plurality of interior walls of the second rigid and sealable enclosure. 
     
     
       15. The container of  claim 14 , further comprising a flexible tube extending between a dispensing port extending through at least a portion of the at least one enclosure wall of the first flexible and the external dispensing port. 
     
     
       16. The container of  claim 11 , wherein the second rigid and sealable enclosure and closure top engage in an airtight sealing arrangement. 
     
     
       17. The container of  claim 11 , wherein the first flexible and sealable enclosure can be completely removed from the second rigid and sealable enclosure. 
     
     
       18. The container of  claim 11 , further comprising a first dispensing port extending through at least a portion of the at least one enclosure wall of the first flexible and sealable enclosure, wherein when the first dispending port is opened and the first flexible and sealable enclosure is compressed at least a portion of the flowable microbubble composition exits the first flexible and sealable enclosure through the first dispensing port. 
     
     
       19. The container of  claim 14 , further comprising a flexible tube extending between a dispensing port extending through at least a portion of the at least one enclosure wall of the first flexible and the external dispensing port, and a compression plunger extending at least partially through the closure top. 
     
     
       20. The container of  claim 19 , wherein when the external dispensing port is opened and the plunger is depressed towards the first flexible and sealable enclosure, at least a portion of the flowable microbubble composition within the first flexible and sealable enclosure exits the second rigid and sealable enclosure through the external dispensing port.